Borderline Resectable Pancreatic Ductal AdenocarcinomaPhase 2NCT07748611
SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Electronic Health Record Review in people with Borderline Resectable Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Ductal Adenocarcinoma, run by Northwestern University at 1 site in United States.
Trial summary
This phase II trial tests the impact of using SMAD4-mutant status to personalize chemotherapy in treating patients with pancreatic ductal adenocarcinoma (PDAC) that can be removed by surgery (resectable) or that may be between resectable and unresectable (borderline resectable) before undergoing surgery (neoadjuvant). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2026to 3 Feb 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed pancreas ductal adenocarcinoma
- Most recent cross-sectional imaging of the chest, abdomen and pelvis will be used to rule out distant metastases (this will have been completed within standard of care timelines which will typically fall within 90 days of registration)
- Patients must have undergone next generation sequencing (NGS) testing on the pre-treatment tumor tissue and must have either SMAD4 mutant or SMAD4 wild-type mutation identified before consenting for this study
- Note: Before consenting to this study, standard of care NGS procedure will be performed on pre-treatment tumor biopsies that are routinely collected through endoscopic biopsy specimens (in-house Oncomine Precision NGS). The results will be documented for this study from clinic notes
- Patients must have resectable/borderline-resectable disease
- Note: National Comprehensive Cancer Network (NCCN) definitions of resectability will be used
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- Patients must be treatment-naïve and clinically fit and eligible for either FOLFIRINOX or gemcitabine/nab-paclitaxel chemotherapy regimens (per treating physician's determination)
- Patients must be ≥ 18 years of age
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients must have adequate organ and bone marrow function as determined by the treating physician to be considered to be clinically fit for the physician-determined chemotherapy regimen
- Patients must agree to use adequate contraception: (e.g. hormonal or barrier method of birth control for a patient of child-bearing potential (POCBP), prior to study entry, and for the duration of study participation. Should a female patient, or a female partner of a patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study doctor immediately. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through the time period indicated for standard of care drugs , after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- POCBP must have a negative pregnancy test prior to registration on study
- Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements
Who cannot join
- Patients with the presence of any of the following genetic or molecular abnormalities:
- Mismatch repair (MMR)-deficiency/Lynch syndrome
- High-frequency microsatellite instability (MSI-H)
- Homologous recombination deficiency (HRD)
- Patients who are currently participating in another study and receiving a study drug
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0
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- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen (per treating physician's determination)
- Patients who are pregnant or nursing
- Patients who have an uncontrolled intercurrent illness (as determined by treating physician), including, but not limited to any of the following:
- Hypertension that is not controlled on medication
- Active infection requiring treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Patient with presence of any concurrent medical or psychiatric condition/social situations which would make them inappropriate candidates for entry into this study or that would limit compliance with study requirements, or would compromise the patient's safety or study endpoints, in the treating investigator's judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Brett L. Ecker, MD, Brett.Ecker@northwestern.edu
Brett L. Ecker, MD
About this study
Official title: SMART-PANC: SMAD4 Tailored Neoadjuvant Therapy for Pancreatic Cancer, A Phase ll Non-Randomized, Single Center Pilot Study
This phase II trial tests the impact of using SMAD4-mutant status to personalize chemotherapy in treating patients with pancreatic ductal adenocarcinoma (PDAC) that can be removed by surgery (resectable) or that may be between resectable and unresectable (borderline resectable) before undergoing surgery (neoadjuvant). PDAC is one of the most aggressive and fastest growing tumors. SMAD4, a tumor suppressor gene, acts like a brake on cell growth and helps to prevent tumor cells from growing. However, losing it makes the tumor more aggressive and often resistant to standard of care (SOC) treatments regimens, such as gemcitabine with nab-paclitaxel and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic (DNA) and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Instead of a one-sized fits all treatment approach with SOC therapies, matching therapy based on SMAD4 mutation status may use this specific genetic weakness against the tumor. This approach to neoadjuvant therapy may dramatically alter the path of treatment and improve outcomes, including complete resection rates, in patients with resectable or borderline resectable PDAC.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the R0/R1 surgical resection rate among patients with SMAD4-mutant pancreatic cancer treated with gemcitabine/nab-paclitaxel (Cohort A).
SECONDARY OBJECTIVES:
- To estimate the trial participation rate among patients approached for enrollment, defined as the proportion of patients who consent and enroll among those approached, with a target participation rate of ≥ 70%, and to monitor this rate continuously during accrual.
II. To estimate the R0/R1 surgical resection rate among SMAD4 wild-type patients treated with physician choice chemotherapy (Cohort B).
III. To determine pathologic response rates, among the subset of patients who reach surgical resection.
IV. To determine the progression free survival (PFS). V. To determine the overall survival (OS).
EXPLORATORY OBJECTIVES:
- To estimate the proportion of R0 resections among patients with SMAD4-mutant pancreatic cancer treated with gemcitabine/nab-paclitaxel (Cohort A) who undergo surgical resection (R0/R1).
II. To estimate the proportion of R0 resections among patients with SMAD4 wild-type patients treated with physician choice chemotherapy (Cohort B) who undergo surgical resection (R0/R1).
III. To compare R0/R1 resection rates between Cohort A (SMAD4-mutant, gemcitabine/nab-paclitaxel) and Cohort B (SMAD4 wild-type, physician choice) in a descriptive, exploratory manner; the study is not powered for formal non-inferiority or superiority testing of this comparison.
IV. To determine the preoperative/neoadjuvant ca19-9 dynamics in both cohorts. V. To determine the preoperative/neoadjuvant circulating tumor DNA (ctDNA) dynamics in both cohorts.
VI. To assess reason for failure to reach surgical resection, categorized by clinical deterioration, patient withdrawal/refusal of surgery, metastatic progression, or local disease progression precluding surgery.
OUTLINE: Patients with SMAD4 alterations are assigned to Cohort A and patients without SMAD4 mutations are assigned to Cohort B.
COHORT A: Patients receive gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) as clinically indicated throughout the study.
COHORT B: Patients receive either physicians choice of either fluorouracil, leucovorin, irinotecan, and oxaliplatin or gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study.
After completion of study treatment, patients are followed up at 30 days from surgical resection then every 3 months for up to 2 years from study enrollment.
- Conditions
- Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
- Being tested
- Biospecimen Collection, Computed Tomography, Electronic Health Record Review, Fluorouracil, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Electronic Health Record ReviewOther
Ancillary studies
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given fluorouracil
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given gemcitabine
IrinotecanDrug
Given irinotecan
LeucovorinDrug
Also called Folinic acid
Given leucovorin
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Nab-paclitaxelDrug
Also called ABI 007, ABI-007, ABI007, Abraxane
Given nab-paclitaxel
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given oxaliplatin
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate
Undergo radiation therapy
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (gemcitabine, nab-paclitaxel) | Experimental | Patients receive gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Drug: Gemcitabine; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Radiation: Radiation Therapy; Procedure: Surgical Procedure |
| Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) | Experimental | Patients receive either physicians choice of either fluorouracil, leucovorin, irinotecan, and oxaliplatin or gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Radiation: Radiation Therapy; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve R0/R1 surgical resection (Cohort A)
Successful surgical resection is defined as macroscopically complete removal of the primary pancreatic tumor, classified as R0 or R1. Will follow the Simon's minimax two-stage design decision rule. The observed R0/R1 resection rate will be summarized descriptively and reported with an exact (Clopper-Pearson) binomial confidence interval.
Measured: Up to 30 days from surgical resection
Secondary outcomes (6)
Trial participation rate
Will be defined as the proportion of patients who consent and enroll among all patients who are approached and eligible for trial participation. Will be summarized using proportions with exact confidence intervals. Feasibility monitoring will occur on an ongoing basis during accrual (e.g. monthly or after every 20 approached eligible patients, whichever occurs first) using cumulative participation rate.
Measured: Up to 2 years
Proportion of patients who achieve R0/R1 surgical resection rate (Cohort B)
Among participants who undergo R0/R1 surgical resection, the proportion achieving R0 resection will be summarized.
Measured: Up to 30 days after surgical resection
Proportion of patients who achieve R0/R1 surgical resection rate (Cohort A)
Among participants who undergo R0/R1 surgical resection, the proportion achieving R0 resection will be summarized.
Measured: Up to 30 days after surgical resection
Pathologic response rates
Pathology reports will be reviewed to determine the College of American Pathologists (CAP) tumor regression score, categorized from 0 (complete response) to 3 (poor or no response). CAP tumor regression scores will be summarized descriptively as frequencies and percentages across categories. The distribution of reasons for failure to reach surgical resection will be summarized descriptively using frequencies and percentages. These summaries may be further stratified by baseline resectability status and SMAD4 mutation status to provide clinical context and inform future trial design.
Measured: Up to 30 days after surgical resection
Progression free survival (PFS)
PFS will be analyzed using Kaplan-Meier methods. The median PFS and corresponding 95% confidence interval will be estimated.
Measured: From enrollment to disease progression or clinical deterioration that precludes complete surgical resection, disease recurrence after surgery, or death from any cause, assessed up to 2 years
Overall survival (OS)
OS will be analyzed using Kaplan-Meier methods. Median OS and corresponding 95% confidence intervals will be reported.
Measured: From enrollment to the date of any cause of death or to the date of last follow-up, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start26 Oct 2026
- Primary completion3 Feb 2030 (estimated)
- Study completion3 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brett L Ecker, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748611
- Sponsor's protocol ID
- NU 26I01
- Other IDs
- NCI-2026-05293, STU00226144, NU 26I01, P30CA060553
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART-PANC: SMAD4 Tailored Neoadjuvant Therapy for Pancreatic Cancer, A Phase ll Non-Randomized, Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT07748611
- Acronym / sponsor ID
- NU 26I01
- Conditions
- Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 3 Feb 2030 (estimated)
- Study completion
- 3 Feb 2031 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial tests the impact of using SMAD4-mutant status to personalize chemotherapy in treating patients with pancreatic ductal adenocarcinoma (PDAC) that can be removed by surgery (resectable) or that may be between resectable and unresectable (borderline resectable) before undergoing surgery (neoadjuvant). PDAC is one of the most aggressive and fastest growing tumors. SMAD4, a tumor suppressor gene, acts like a brake on cell growth and helps to prevent tumor cells from growing. However, losing it makes the tumor more aggressive and often resistant to standard of care (SOC) treatments regimens, such as gemcitabine with nab-paclitaxel and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic (DNA) and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Instead of a one-sized fits all treatment approach with SOC therapies, matching therapy based on SMAD4 mutation status may use this specific genetic weakness against the tumor. This approach to neoadjuvant therapy may dramatically alter the path of treatment and improve outcomes, including complete resection rates, in patients with resectable or borderline resectable PDAC.
Detailed description
PRIMARY OBJECTIVE:
- To determine the R0/R1 surgical resection rate among patients with SMAD4-mutant pancreatic cancer treated with gemcitabine/nab-paclitaxel (Cohort A).
SECONDARY OBJECTIVES:
- To estimate the trial participation rate among patients approached for enrollment, defined as the proportion of patients who consent and enroll among those approached, with a target participation rate of ≥ 70%, and to monitor this rate continuously during accrual.
II. To estimate the R0/R1 surgical resection rate among SMAD4 wild-type patients treated with physician choice chemotherapy (Cohort B).
III. To determine pathologic response rates, among the subset of patients who reach surgical resection.
IV. To determine the progression free survival (PFS). V. To determine the overall survival (OS).
EXPLORATORY OBJECTIVES:
- To estimate the proportion of R0 resections among patients with SMAD4-mutant pancreatic cancer treated with gemcitabine/nab-paclitaxel (Cohort A) who undergo surgical resection (R0/R1).
II. To estimate the proportion of R0 resections among patients with SMAD4 wild-type patients treated with physician choice chemotherapy (Cohort B) who undergo surgical resection (R0/R1).
III. To compare R0/R1 resection rates between Cohort A (SMAD4-mutant, gemcitabine/nab-paclitaxel) and Cohort B (SMAD4 wild-type, physician choice) in a descriptive, exploratory manner; the study is not powered for formal non-inferiority or superiority testing of this comparison.
IV. To determine the preoperative/neoadjuvant ca19-9 dynamics in both cohorts. V. To determine the preoperative/neoadjuvant circulating tumor DNA (ctDNA) dynamics in both cohorts.
VI. To assess reason for failure to reach surgical resection, categorized by clinical deterioration, patient withdrawal/refusal of surgery, metastatic progression, or local disease progression precluding surgery.
OUTLINE: Patients with SMAD4 alterations are assigned to Cohort A and patients without SMAD4 mutations are assigned to Cohort B.
COHORT A: Patients receive gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) as clinically indicated throughout the study.
COHORT B: Patients receive either physicians choice of either fluorouracil, leucovorin, irinotecan, and oxaliplatin or gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study.
After completion of study treatment, patients are followed up at 30 days from surgical resection then every 3 months for up to 2 years from study enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (gemcitabine, nab-paclitaxel) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic Health Record Review, Drug: Gemcitabine, Procedure: Magnetic Resonance Imaging, Drug: Nab-paclitaxel, Radiation: Radiation Therapy, Procedure: Surgical ProcedurePatients receive gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study. |
| Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic Health Record Review, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Irinotecan, Drug: Leucovorin, Procedure: Magnetic Resonance Imaging, Drug: Nab-paclitaxel, Drug: Oxaliplatin, Radiation: Radiation Therapy, Procedure: Surgical ProcedurePatients receive either physicians choice of either fluorouracil, leucovorin, irinotecan, and oxaliplatin or gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically confirmed pancreas ductal adenocarcinoma
- Patients must have undergone next generation sequencing (NGS) testing on the pre-treatment tumor tissue and must have either SMAD4 mutant or SMAD4 wild-type mutation identified before consenting for this study
- Patients must have resectable/borderline-resectable disease
- Patients must be treatment-naïve and clinically fit and eligible for either FOLFIRINOX or gemcitabine/nab-paclitaxel chemotherapy regimens (per treating physician's determination)
- Patients must be ≥ 18 years of age
Key exclusion criteria (15 listed)
- Patients with the presence of any of the following genetic or molecular abnormalities:
- Patients who are currently participating in another study and receiving a study drug
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen (per treating physician's determination)
- Patients who are pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| Electronic Health Record ReviewAncillary studies | Other | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| FluorouracilAlso: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedioneGiven fluorouracil | Drug | Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| GemcitabineAlso: dFdC, dFdCyd, DifluorodeoxycytidineGiven gemcitabine | Drug | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| IrinotecanGiven irinotecan | Drug | Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| LeucovorinAlso: Folinic acidGiven leucovorin | Drug | Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| Nab-paclitaxelAlso: ABI 007, ABI-007, ABI007, AbraxaneGiven nab-paclitaxel | Drug | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| OxaliplatinAlso: 1-OHP, Ai Heng, Aiheng, DacotinGiven oxaliplatin | Drug | Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| Radiation TherapyAlso: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, IrradiateUndergo radiation therapy | Radiation | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, Surgery, NOSUndergo surgical resection | Procedure or surgery | Cohort A (gemcitabine, nab-paclitaxel), Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX) |
Primary outcome
Proportion of patients who achieve R0/R1 surgical resection (Cohort A)
Time frame: Up to 30 days from surgical resection
Successful surgical resection is defined as macroscopically complete removal of the primary pancreatic tumor, classified as R0 or R1. Will follow the Simon's minimax two-stage design decision rule. The observed R0/R1 resection rate will be summarized descriptively and reported with an exact (Clopper-Pearson) binomial confidence interval.
6 secondary outcomes
Trial participation rate
Time frame: Up to 2 years
Proportion of patients who achieve R0/R1 surgical resection rate (Cohort B)
Time frame: Up to 30 days after surgical resection
Proportion of patients who achieve R0/R1 surgical resection rate (Cohort A)
Time frame: Up to 30 days after surgical resection
Pathologic response rates
Time frame: Up to 30 days after surgical resection
Progression free survival (PFS)
Time frame: From enrollment to disease progression or clinical deterioration that precludes complete surgical resection, disease recurrence after surgery, or death from any cause, assessed up to 2 years
Overall survival (OS)
Time frame: From enrollment to the date of any cause of death or to the date of last follow-up, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brett L Ecker, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Electronic Health Record Review in people with Borderline Resectable Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Ductal Adenocarcinoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (3126951301, cancer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieve R0/R1 surgical resection (Cohort A) (time frame: Up to 30 days from surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.